Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA.
Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA.
Clin Ther. 2021 Feb;43(2):380-395. doi: 10.1016/j.clinthera.2020.12.011. Epub 2021 Jan 24.
Title IX, § 921 of the Food and Drug Administration (FDA) Amendments Act of 2007 requires the FDA to mine data on a regular basis, using its adverse events database, the FDA Adverse Event Reporting System, to identify potential signals of serious risks/new safety information. This review of the FDA's quarterly web-posted results is the first to document the contributions of the program to maintaining the continued safe use of approved pharmaceutical drugs/biologics and the lessons that have emerged from this rich experience.
Details on proprietary prescription drugs/biologics, generic prescription drugs, and over-the-counter drugs were downloaded from the quarterly posts that begin in first quarter of 2008. Key information was tabulated, including proprietary and generic names of products or classes of products, the identified potential signals of serious risks, the labeling-decision category (updated, no action is necessary at this time, or evaluating the need for regulatory action), the labeling section (Warnings and Precautions, Adverse Reactions, Drug Safety Communications, Contraindications, or Boxed Warnings), and estimated times to updated decisions.
Since the beginning of the FDAAA Section 921 posting requirement, the FDA has posted 555 potential signals of serious risk or new safety information. Of these, there have been 262 posts (47%) that resulted in decisions requiring updated product labeling, 75 posts (14%) that resulted in decisions that no action was necessary, and 218 posts (39%) indicating that the FDA was evaluating the need for regulatory action. Of the 262 posts that required updating one or more sections of a product label, there was a preponderance of Warnings and Precautions, with 172 (66%); followed by Adverse Reactions, with 114 (44%); Drug Safety Communications, 44 (18%); Contraindications, 27 (10%); and Boxed Warnings, 19 (7%). The median times to update decisions were 12 months for Warnings & Precautions, Adverse Reactions, and Boxed Warnings, and 11 months for Contraindications.
Important themes from the present analysis include the following: (1) nearly 80% of posts resulted in updated product labeling; (2) 20% of decisions concerned classes of proprietary and generic drug/biologic products; (3) product-use errors, such as name confusion, continue to be important; (4) the safe use of pharmaceuticals in children is gaining attention but still has a long way to go; and (5) drug-drug interactions are of continuing concern. The FDA Amendments Act § 921 program will continue to have an important place in the future of pharmacovigilance practices.
2007 年《食品和药物管理局（FDA）修正案》第 921 条要求 FDA 定期利用其不良事件数据库（FDA 不良事件报告系统）挖掘数据，以识别严重风险/新安全信息的潜在信号。本季度对 FDA 季度网络发布结果的审查首次记录了该计划对维持已批准的药物/生物制品持续安全使用的贡献，以及从这一丰富经验中获得的经验教训。
从 2008 年第一季度开始的季度帖子中下载了专利处方药/生物制剂、仿制药和非处方药的详细信息。对关键信息进行了制表，包括产品或产品类别（产品名称、通用名称）的专有和通用名称、确定的严重风险潜在信号、标签决策类别（更新、此时无需采取行动或评估是否需要监管行动）、标签部分（警告和注意事项、不良反应、药物安全通讯、禁忌症或框警示）和估计更新决策的时间。
自 FDAAA 第 921 条发布要求开始以来，FDA 已发布了 555 个严重风险或新安全信息的潜在信号。其中，有 262 个（47%）帖子导致需要更新产品标签的决定，75 个（14%）帖子导致无需采取行动的决定，218 个（39%）帖子表明 FDA 正在评估是否需要监管行动。在需要更新产品标签的 262 个帖子中，警告和注意事项占绝大多数，有 172 个（66%）；其次是不良反应，有 114 个（44%）；药物安全通讯 44 个（18%）；禁忌症 27 个（10%）；框警示 19 个（7%）。更新决策的中位数时间为 12 个月（警告和注意事项、不良反应和框警示）和 11 个月（禁忌症）。
本分析的重要主题包括以下内容：（1）近 80%的帖子导致更新了产品标签；（2）20%的决定涉及专利和仿制药/生物制品的类别；（3）产品使用错误，如名称混淆，仍然是一个重要问题；（4）儿童药物安全使用问题越来越受到关注，但仍有很长的路要走；（5）药物相互作用仍然是一个令人关注的问题。FDA 修正案第 921 条计划将在未来的药物警戒实践中继续发挥重要作用。
